HealthyPhase 1NCT04958772
Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers
A Phase 1 study testing Filgrastim Megalabs and Granulokine in people with Healthy, run by Megalabs.
Trial summary
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Filgrastim Megalabs and Granulokine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
- Males aged between 18 and 55 years
- Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
- Not indicating any evidence of disease
- Body weight between 60-100 kg
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 Kg / m2
- Negative test for coronavirus
Who cannot join
- Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods)
- Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods)
- Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods)
- Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma
- Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis
- Participants with chronic diseases and, therefore, who regularly use medications
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- Being a smoker or quitting less than 6 months ago
- Participants who consume more than 5 cups of tea or coffee a day and who cannot - abstain during the trial period
- History of alcohol and illicit drug abuse
- Electrocardiogram (ECG) findings that, at the investigator's discretion, may compromise participation in the trial
- History or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug
- Use of lithium 2 weeks before and / or after medication administration
- Participants who are hypersensitive or contraindicated to use any of the components of the formulation
- Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Resolution CNS 251, of August 7, 1997, item III, subitem J)
- Have donated blood (> 500 mL) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form
- Have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Trials Phase I, Single-Centric, Open, Randomized, Crossed, For Comparative Evaluation Of The Pharmacokinetic And Pharmacodynamic Profile Of The Filgrastim Injectable Solution, In Relation To The Comparison Granulokine®, Ltda. After Subcutaneous Multiple Administration In Healthy Participants
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen.
- Conditions
- Healthy
- Being tested
- Filgrastim Megalabs, Granulokine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filgrastim MegalabsBiological
Filgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose
GranulokineBiological
Granulokine 5 μg/Kg/day, subcutaneous single dose
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim Megalabs | Experimental | Filgrastim Megalabs injectable 5 μg/Kg/day in a single subcutaneous application during 5 days Receives: Biological: Filgrastim Megalabs; Biological: Granulokine |
| Granulokine | Active comparator | Granulokine injectable 5 μg/Kg/day in a single subcutaneous application during 5 days Receives: Biological: Filgrastim Megalabs; Biological: Granulokine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of AUC 0-t in healthy volunteers for test and reference.
Measured: 17 days
Evaluation of Cmax in healthy volunteers for test and reference.
Measured: 17 days
Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference.
Measured: 17 days
Secondary outcomes (1)
Evaluation of CD34+ count for test and reference
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Nov 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Megalabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Satish Kumar, MD, Principal investigator, Azidus Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958772
- Sponsor's protocol ID
- LATIM
- Status last verified
- Aug 2024
- First submitted
- 6 Jul 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials Phase I, Single-Centric, Open, Randomized, Crossed, For Comparative Evaluation Of The Pharmacokinetic And Pharmacodynamic Profile Of The Filgrastim Injectable Solution, In Relation To The Comparison Granulokine®, Ltda. After Subcutaneous Multiple Administration In Healthy Participants
- ClinicalTrials.gov ID
- NCT04958772
- Acronym / sponsor ID
- LATIM
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MegalabsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgrastim Megalabs | Experimental | Biological: Filgrastim Megalabs, Biological: GranulokineFilgrastim Megalabs injectable 5 μg/Kg/day in a single subcutaneous application during 5 days |
| Granulokine | Active comparator | Biological: Filgrastim Megalabs, Biological: GranulokineGranulokine injectable 5 μg/Kg/day in a single subcutaneous application during 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
- Males aged between 18 and 55 years
- Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
- Not indicating any evidence of disease
- Body weight between 60-100 kg
Key exclusion criteria (16 listed)
- Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods)
- Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods)
- Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods)
- Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma
- Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filgrastim MegalabsFilgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose | Biological | Filgrastim Megalabs, Granulokine |
| GranulokineGranulokine 5 μg/Kg/day, subcutaneous single dose | Biological | Filgrastim Megalabs, Granulokine |
Primary outcome
Evaluation of AUC 0-t in healthy volunteers for test and reference.
Time frame: 17 days
Evaluation of Cmax in healthy volunteers for test and reference.
Time frame: 17 days
Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference.
Time frame: 17 days
1 secondary outcome
Evaluation of CD34+ count for test and reference
Time frame: 17 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish Kumar, MD principal investigator
Azidus Principal Investigator
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Filgrastim Megalabs and Granulokine in people with Healthy, run by Megalabs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos Giusti, MD (+598926838000 ext. 3100, mgiusti@megalabs.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of AUC 0-t in healthy volunteers for test and reference. (time frame: 17 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.